Diabetic Retinopathy Functional Evaluation Study: Monitoring Carotenoid Vitamins Treatment Using ERG
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Full-field flicker ERG (ffERG) Measurements: magnitude (microvolts) and the phase (milliseconds) and the area ratio for magnitude and the area ratio for Phase
研究概览
简要总结
To evaluate the differences in retinal function as measured by ERG in diabetics with and without retinopathy 2) the ability of the Chromatic Electroretinogram (chERG) to detect changes in global retinal function following treatment with Carotenoid Vitamins supplement in patients with diabetic retinopathy (DR). 3) the ability of the Full Field flicker (ffERG) to detect changes in global retinal function following treatment with Carotenoid Vitamins supplement in patients with diabetic retinopathy (DR).
- Changes in retinal function as observed by OCT-Angiography, following treatment with Carotenoid Vitamins supplement in patients with diabetic retinopathy (DR).
详细描述
This prospective, study has cross-sectional analysis of ERG functions in a group of diabetics with and without retinopathy. Both Chromatic ERG and Full field ERG (NOVA, Diopsys, Inc. Pine Brook, NJ) will be utilized in the study. Subsequently individuals with an outside normal limit outcome on at least one ERG test will be invited to be part of the longitudinal study. Individuals with abnormal ERG results will be asked to take the carotenoid vitamin supplement (ZeaVision DVS supplement) and the baseline data will be compared to the values at one, three- and six-month follow-up.
The primary endpoint of a patient's follow-up will be at 6 months. The study will be performed at three sites. Western University of Health Sciences, Harpers Pointe Eye Associates (Externship site College of Optometry, Western University of Health Sciences) and Oklahoma College of Optometry, Northeastern State University, Tahlequah, Oklahoma.
The clinical study plan will be reviewed and approved by Eye Care Center of the Western University of Health Sciences Institutional Review Board (IRB). Harpers Pointe Eye Associates will be covered under an externship site of Western University of Health Sciences.
NSUOCO will apply for a separate IRB review at their own site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-80 years
- •History of Diabetes for at least > 5years
- •No retinopathy, Mild or Moderate Non-Proliferative diabetic retinopathy
- •Diabetes without retinopathy (Appendix A)
- •Mild to moderate NPDR as defined by the American Academy of Ophthalmology7 (Appendix A)
排除标准
- •• History of any systemic or ophthalmic condition (other than diabetic retinopathy) capable of affecting vision
- •Presence of Diabetic Macular Edema
- •History of intraocular surgery, including macular or panretinal photocoagulation laser (except uncomplicated cataract or keratorefractive surgery more than 6 months prior to enrollment)
- •History of treatment affecting vision, influencing reaction time and/or drugs indicating severe general diseases (eg. Hydroxychloroquine, tamoxifen, dexamethasone, triamcinolone, fluocinolone, etc.)
- •Spherical refraction outside ±5.0 D or cylinder correction outside ±3.0 D
- •Inability to obtain reliable Chromatic ERG test
- •Pregnant and nursing women
- •Allergy to the supplement or any of its ingredients
- •Any subject that all ERG study tests or the OCT angiography cannot be obtained reliably.
结局指标
主要结局
Full-field flicker ERG (ffERG) Measurements: magnitude (microvolts) and the phase (milliseconds) and the area ratio for magnitude and the area ratio for Phase
时间窗: Change from Baseline to 6 months
The Flicker ERG will be recorded using a commercially available system, Diopsys® NOVA (Diopsys, Inc., Pine brook, NJ), version 2.19.19778.7332). The Flicker ERG will be consecutively recorded from both eyes by means of adhesive skin electrodes on the lower eyelid and skin. The stimulus will consist of white flashes flickering at 32 Hz over a white background as well as a sequence of 6 steps of increasing luminance.
Chromatic ERG (ChERG) Outcome Measurements: B wave and PhNR latency (milliseconds) Full field ERG outcome measurements and Chromatic ERG Outcome Measurements
时间窗: Change from Baseline to 6 months
The Chromatic Electroretinogram (chERG) and the full field ERG will be recorded using a commercially available system Diopsys® NOVA (Diopsys, Inc. Pine Brook, New Jersey). The Red-Blue stimulus will be presented using a mini-Ganzfeld handheld device. The entire process consists of two tests per eye, with twenty-five seconds allocated for each test; thus, the total duration of the test is one hundred seconds. The chERG will be consecutively recorded from both eyes by means of proprietary adhesive skin electrodes on the lower eyelid and forehead.
次要结局
- Macular pigment optical density (MPOD in relative density units)(Change from Baseline to 6 months)
- Optical coherence tomography angiography (OCTA): radial macular and optic nerve capillary density (number/square millimeter)(Change from Baseline to 6 months)